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© 2020 MJH Life Sciences and BioPharm International. All rights reserved.
© 2020 MJH Life Sciences™ and BioPharm International. All rights reserved.
Automation, digitalization, and supply-chain strategies help mitigate vulnerabilities.
EUA for Lilly's mAb treatment; Pifzer reports 90% vaccine efficacy in interim results
November 24, 2020
FDA granted fast track designation for AB201, a small recombinant protein that is a potent, selective inhibitor of tissue factor, for the potential treatment of COVID-19.
The EC’s approval was based on positive results from a Phase III clinical trial that demonstrated a statistically significant and clinically meaningful improvement in patients compared to chemotherapy.
Wacker will support production of CureVac’s COVID-19 mRNA-based vaccine candidate at its biotech site in Amsterdam, with production scheduled to start in the first half of 2021.
Dolomite Microfluidics and MilliporeSigma have begun a collaboration to release off-the-shelf microfluidic device kits for the fabrication of PLGA particles.
The new powerful, precise, and compact instrument can be retrofitted for point-of-care clinical testing at urgent care facilities, hospitals, or physicians’ offices.
The expansion of the companies’ partnership will integrate lead optimization efforts to advance cancer immune therapy drug discovery.
The EC’s approval comes after positive results from seven Phase II and III randomized, active-controlled, multi-center studies.
The companies have entered into an agreement for the technology transfer and clinical manufacturing of Mustang’s MB-107 lentiviral gene therapy program for the treatment of X-linked severe combined immunodeficiency, also known as bubble boy disease, in Europe.
The expansion will include a new 25,000-ft2 warehouse, a filling line for flexible plastic containers, a high-speed automated syringe fill line with the ability to fill up to 600 units per minute, and a high-speed automated visual inspection line.
The acquisition gives Merck a new Phase III COVID-19 therapeutic candidate, CD24Fc, a fusion protein that targets the innate immune system, in its pipeline.
November 23, 2020
The new super plant, being built in Incheon, South Korea, will have a total biopharmaceutical manufacturing capacity of 256,000 L.
The companies have formed a long-term manufacturing agreement to accelerate the global supply for Lilly’s COVID-19 antibody therapeutics.
The agreement follows a recent announcement that Sartorius plans to invest $100 million in Songdo, South Korea’s bio cluster.
The agreement will allow Roche to use CEVEC’s proprietary ELEVECTA technology, which is designed to enable fully scalable, high-performance AAV vector production in suspension bioprocesses.
The partners have established PathoQuest, Inc., a US subsidiary, and will construct an NGS-based testing lab at Charles River’s Wayne, PA, site.
The Trump administration unveiled a new drug price control policy, drawing opposition from pharma manufacturers and pharmacy benefit managers.
When administered together in clinical trials, casirivimab and imdevimab were shown to lessen COVID-19 hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo.
An independent data safety monitoring board found that clinical trial data demonstrated that the vaccine candidate met its primary endpoint and demonstrated protection from COVID-19.
Following an EUA application from Pfizer and NioNTech, FDA outlines the process for committee and agency review.
November 20, 2020
Apiject was approved for a $590-million loan from the US to build in-country capacity for COVID-19 vaccines and therapeutics.